Dutch Ophthalmic USA, Inc. recalls The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , P…
- Recall date
- May 21, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2252-2021
- FDA classification
- Class II
- Brand / firm
- Dutch Ophthalmic USA, Inc.
- Sold / distributed
- US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Why it was recalled
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
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